OBJECTIVE: To describe the safety and efficacy of thoracoamniotic shunting for fetal pleural effusion using a double-basket catheter with a very small diameter (1.47 mm). METHOD: In this 2-year multicenter, prospective single-arm clinical study registered with the University hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN00001095); shunting was performed between 18w0d and 33w6d of gestation with this catheter in cases of fetal pleural effusions reaccumulating after thoracocentesis. The primary endpoint measures were maternal and fetal adverse effects and survival in the neonatal period. RESULTS: A total of 24 cases were included, of which 17 had hydrops (71%). The median gestational ages at shunting and delivery were 27.4 and 34.8 weeks, respectively. There were no fetal deaths, lung injuries, or severe maternal complications. Preterm rupture of the membranes occurred in 7/24 (29%) cases at a median of 62 days after the shunting. Preterm rupture of the membranes within 28 days of the procedure occurred in 1/24 (4%) cases. Catheter displacement towards the fetal thoracic cavity occurred in 4/42 (10%) cases. The overall survival rate was 79% (19/24), whereas it was 71% (12/17) in the cases with hydrops. CONCLUSION: Drainage of fetal pleural effusions with a double-basket shunt is safe and effective, and the shunt could be an alternative device.
OBJECTIVE: To describe the safety and efficacy of thoracoamniotic shunting for fetal pleural effusion using a double-basket catheter with a very small diameter (1.47 mm). METHOD: In this 2-year multicenter, prospective single-arm clinical study registered with the University hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN00001095); shunting was performed between 18w0d and 33w6d of gestation with this catheter in cases of fetal pleural effusions reaccumulating after thoracocentesis. The primary endpoint measures were maternal and fetal adverse effects and survival in the neonatal period. RESULTS: A total of 24 cases were included, of which 17 had hydrops (71%). The median gestational ages at shunting and delivery were 27.4 and 34.8 weeks, respectively. There were no fetal deaths, lung injuries, or severe maternal complications. Preterm rupture of the membranes occurred in 7/24 (29%) cases at a median of 62 days after the shunting. Preterm rupture of the membranes within 28 days of the procedure occurred in 1/24 (4%) cases. Catheter displacement towards the fetal thoracic cavity occurred in 4/42 (10%) cases. The overall survival rate was 79% (19/24), whereas it was 71% (12/17) in the cases with hydrops. CONCLUSION: Drainage of fetal pleural effusions with a double-basket shunt is safe and effective, and the shunt could be an alternative device.